A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Optison Online, Description, Chemistry, Ingredients - Perflutren
Optison Online, Description, Chemistry, Ingredients - Perflutren
DESCRIPTION
OPTISON™ (Perflutren Protein-Type A Microspheres
for Injection, USP) is a sterile non-pyrogenic suspension of microspheres of
human serum albumin with perflutren for contrast enhancement during the indicated
ultrasound imaging procedures. The vial contains a clear liquid lower layer
and a white upper layer that, after resuspension by gentle mixing, provides
a homogeneous, opaque, milky-white suspension for intravenous injection.
Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-perflutren
with a molecular weight of 188, an empirical formula of C3F8
Each mL of OPTISON contains 5.0-8.0x108 protein-type
A microspheres, 10 mg Albumin Human, USP, 0.22 ± 0.11 mg/mL perflutren, 0.2
mg N-acetyltryptophan, and 0.12 mg caprylic acid in 0.9% aqueous sodium chloride.
The headspace of the vial is filled with perflutren gas. The pH is adjusted
to 6.4-7.4. The protein in the microsphere shell makes up approximately 5-7%
(w/w) of the total protein in the liquid. The microsphere particle size parameters
are listed in Table 1.
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Table 1 Microsphere Particle Size Parameters
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Mean diameter(range)
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3.0-4.5µm (max. 32.0µm)
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Percent less than 10µm
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95%
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